Renal AnemiaPhase 4NCT03388385

Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD

A Phase 4 study testing Sodium Chloride 0.9% Intravenous Solution and Ferinject in people with Renal Anemia and Iron Toxicity, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to investigate the effects of acute intravenous iron administration on the endothelial function in non-dialysis Chronic Kidney Disease stages G3-G5 patients with anemia and iron deficiency, in relation to changes in oxidative and nitrosative status. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Anemia, Iron Toxicity, Oxidative Stress
What is being tested?: Sodium Chloride 0.9% Intravenous Solution and Ferinject
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteRomania
Study dates: 20 Sep 2017to 20 Dec 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic kidney disease stages G3-G5 (defined according to KDIGO criteria);
Anemia (defined according to KDIGO criteria) and iron deficiency defined as serum ferritin < 100 ng/mL and/or TSAT < 20% (KDIGO).

Who cannot join

contraindications of intravenous iron therapy: iron allergy, active infection, hemochromatosis, iron overload (serum ferritin > 500 ng/mL and/or transferrin saturation > 50%);
treatment with iron and erythropoiesis-stimulating agents (at the time of recruitment and 6 months previously);
active smoker status;
antioxidant food supplements treatment in the last 3 months;
clinically manifest bleeding;
another cause of anemia (hemoglobinopathies, vitamin B12 and/or folic acid deficiency suggested by the megaloblastic peripheral blood smears's appearance, multiple myeloma and other paraproteinemias);

Show all 14Show fewer

severe anemia (Hb < 7 g/dl);
baseline FMD < 7% (the existence of atherosclerosis which limits arterial reactivity);
cancer (currently or in the past 6 months);
hepatopathies (increased serum transaminases ≥ 3 x normal value) or hepatic impairment ≥ grade Child B;
autoimmune disorders or significant inflammation (as defined by C-reactive protein > 5 mg/L);
pregnancy or lactation;
participation in other clinical trials over the upast 3 months;
patient unwillingness.

Trial locations and contacts

1 site in 1 country.

Romania1 site

"Dr. Carol Davila" Teaching Hospital of Nephrology
Bucharest

Other trials in Romania

About this study

Official title: The Effects of a Single Intravenous Iron Upon Vascular Endothelium and Some Parameters of Oxidative Stress in Patients With Non-dialysis Chronic Kidney Disease

Conditions: Renal Anemia, Iron Toxicity, Oxidative Stress, Endothelial Dysfunction
Being tested: Sodium Chloride 0.9% Intravenous Solution, Ferinject
Keywords: CKD, anemia, iron, endothelial dysfunction, oxidative stress
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium Chloride 0.9% Intravenous SolutionDrug
Also called Physiologic saline
Physiologic saline infusion will be infused in day 1.
FerinjectDrug
Also called Ferric carboxymaltose
Ferric carboxymaltose will be infused in day 2.

Study groups in NCT03388385
Study group	Role	What they receive
Placebo	Placebo comparator	Intervention: 250 mL Sodium Chloride 0.9% Intravenous Solution, representing control infusion, over 30 minutes. Receives: Drug: Sodium Chloride 0.9% Intravenous Solution; Drug: Ferinject
Ferric carboxymaltose	Active comparator	Intervention: 1000 mg Ferinject in 250 mL 0.9%NaCl, representing medication in study infusion, over 30 minutes. Receives: Drug: Sodium Chloride 0.9% Intravenous Solution; Drug: Ferinject

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect on endothelial function
Description of the endothelial function variation (changing in flow-mediated vasodilatation (FMD) endothelium-dependent, and also in serum sICAM-1, sVCAM-1 and nitric oxide metabolism parameters ) after administration of a single intravenous dose of iron versus a control solution, in CKD non-dialysis patients.
Measured: through study completion, an average of 1 year
Oxidative stress
Description of some free radicals production's markers (lipid peroxidation and carbonyl stress assessment) and in antioxidant system in plasma markers variation after administration of a single intravenous iron dose versus a control solution, in non-dialysis CKD subjects.
Measured: through study completion, an average of 1 year

Secondary outcomes (1)

Correlation between endothelial dysfunction and oxidative stress markers
Evaluation of correlations between changes in oxidative stress parameters and endothelial function after a single intravenous iron administration compared to a control solution in non-dialysis CKD subjects.
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 201720 Dec 2022

First posted3 Jan 2018
Study start20 Sep 2017
Primary completion30 Dec 2020
Study completion20 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal AnemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03388385
Sponsor's protocol ID: 10488/19.04.2016
Status last verified: Aug 2022
First submitted: 18 Dec 2017
Last updated: 16 Aug 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
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All Renal Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of a Single Intravenous Iron Upon Vascular Endothelium and Some Parameters of Oxidative Stress in Patients With Non-dialysis Chronic Kidney Disease
ClinicalTrials.gov ID: NCT03388385
Acronym / sponsor ID: 10488/19.04.2016
Conditions: Renal Anemia, Iron Toxicity, Oxidative Stress, Endothelial Dysfunction
Keywords: CKD, anemia, iron, endothelial dysfunction, oxidative stress
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (actual)
Lead sponsor: Carol Davila University of Medicine and PharmacyUniversity, hospital or other
Collaborators: S.C. Sanador S.R.L
Study start: 20 Sep 2017 (actual)
Primary completion: 30 Dec 2020 (actual)
Study completion: 20 Dec 2022 (estimated)
First posted: 3 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Sodium Chloride 0.9% Intravenous Solution, Drug: FerinjectIntervention: 250 mL Sodium Chloride 0.9% Intravenous Solution, representing control infusion, over 30 minutes.
Ferric carboxymaltose	Active comparator	Drug: Sodium Chloride 0.9% Intravenous Solution, Drug: FerinjectIntervention: 1000 mg Ferinject in 250 mL 0.9%NaCl, representing medication in study infusion, over 30 minutes.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Chronic kidney disease stages G3-G5 (defined according to KDIGO criteria);
Anemia (defined according to KDIGO criteria) and iron deficiency defined as serum ferritin < 100 ng/mL and/or TSAT < 20% (KDIGO).

Key exclusion criteria (14 listed)

contraindications of intravenous iron therapy: iron allergy, active infection, hemochromatosis, iron overload (serum ferritin > 500 ng/mL and/or transferrin saturation > 50%);
treatment with iron and erythropoiesis-stimulating agents (at the time of recruitment and 6 months previously);
active smoker status;
antioxidant food supplements treatment in the last 3 months;
clinically manifest bleeding;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium Chloride 0.9% Intravenous SolutionAlso: Physiologic salinePhysiologic saline infusion will be infused in day 1.	Drug	Ferric carboxymaltose, Placebo
FerinjectAlso: Ferric carboxymaltoseFerric carboxymaltose will be infused in day 2.	Drug	Ferric carboxymaltose, Placebo

Primary outcome

Effect on endothelial function
Time frame: through study completion, an average of 1 year
Description of the endothelial function variation (changing in flow-mediated vasodilatation (FMD) endothelium-dependent, and also in serum sICAM-1, sVCAM-1 and nitric oxide metabolism parameters ) after administration of a single intravenous dose of iron versus a control solution, in CKD non-dialysis patients.
Oxidative stress
Time frame: through study completion, an average of 1 year
Description of some free radicals production's markers (lipid peroxidation and carbonyl stress assessment) and in antioxidant system in plasma markers variation after administration of a single intravenous iron dose versus a control solution, in non-dialysis CKD subjects.

1 secondary outcome

Correlation between endothelial dysfunction and oxidative stress markers
Time frame: through study completion, an average of 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.

Related trials for Renal Anemia

Active, not recruitingObservational study
A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia
Renal Anemia
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruitingPhase 1
Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
Chronic Kidney Disease, Anemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gabriel Mircescu, Professor study chair

Carol Davila University of Medicine and Pharmacy

Cristina Capusa, Assoc. Prof. study director

Carol Davila University of Medicine and Pharmacy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on endothelial function (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03388385.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.